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Basaglar

insulin glargine

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Basaglar
Proper name
insulin glargine
Licence type
351(a)
BLA number
205692
Applicant
Eli Lilly and Company
Center
CDER
Presentations
2
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Disc December 16, 2015
300UNITS/3ML (100UNITS/ML) Injection Subcutaneous Autoinjector Rx November 15, 2019

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity